Evaluation of guidelines for clinical trials of traditional plant medicines

Abstract

The World Health Organization estimates that 4 billion people use herbal medicine for some aspect of primary health care. These herbal products are however mostly used without the necessary clinical trial done to prove their pharmacological activities and, therefore, their quality, efficacy and safety. It was the objective of this study to review the current international guidelines for the evaluation of herbal medicine; to gain a perspective on the number, type and quality of clinical trials that have been done on herbal medicine and to adopt a set of guidelines that could be used to conduct trial on a traditional herbal medicine used in South Africa. To verify these guidelines, a protocol for a clinical trial was drafted and submitted for approval to the regulatory and ethical authorities in South Africa.